Distress In CErvical Cancer Patients and Partners
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorComprehensive Cancer Centre The Netherlands
About this trial
Rationale: A growing number of cervical cancer patients live years beyond their cancer diagnosis and ultimately survive their disease. Cervical cancer patients report higher levels of psychological distress compared to other (gynecological) cancer types, resulting in physical and psychosocial limitations. The mechanisms explaining why some patients do, and others do not experience persistent psychological distress after cervical cancer remain unclear.
Objective: Gain insight into the mechanisms explaining psychological distress (i.e. anxiety, depression, cancer worry, perceived stress) in a prospective population-based sample of cervical cancer patients. Factors to be studied include characteristics of the individual (demographical and clinical, including comorbidities), characteristics of the environment ((sexual) relationships), biological function (cortisol, melatonin and sex hormone production assessed in scalp hair, inflammation and telomere length assessed in blood, overall quality of life (EORTC QLQ-C30), symptoms (EORTC QLQ-CX24), functional status (physical activity and sleep measured using the Actigraph activity tracker, and food intake measured using the online 'Eetmeter'), and general health perceptions (B-IPQ). The second aim is to assess the impact of cervical cancer on partners' distress (cancer worry, illness perceptions, relationship quality, dyadic coping).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Newly diagnosed with cervical cancer stage I, II or III
>18 years or older
Disqualifiers
Participants with cognitive impairment will not be included because of expected difficulties in completing the questionnaires without assistance.
Participants who are not able to read or write Dutch will be excluded, as they are not able to complete a Dutch questionnaire.
Partner of patient participating in the study
>18 years
Trial population
All newly diagnosed I-III stage cervical cancer patients that receive primary treatment in one of the treatment centres will be identified by their treating gynaecologist. Patients will be invited before the start of treatment and will be followed until 10 years after diagnosis. Additionally, patients will be asked to invite their partner to participate.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
832 Participants
are grouped into 1 trial groupGroup A: Cervical cancer patients and their partners
Trial outcomes
Primary outcomes
1
Anxiety/ depression
Hospital Anxiety and Depression Scale (1-21, higher scores indicate more anxiety or depression)
Time frame
24 monthsSecondary outcomes
1
Cancer worry
Impact of Cancer version 2 (Worry Scale) (0-5, higher scores indicate more worry)
Time frame
24 months2
Perceived stress
Perceived Stress Scale (0-40, higher scores indicate more perceived stress)
Time frame
24 months3
Health-related quality of life
EORTC Quality of Life Questionnaire (QLQC30) (0-100, higher scores indicate better quality of life or more symptoms)
Time frame
24 months4
Cervical cancer health-related quality of life
EORTC Cervical Cancer Module (CX24) (0-100, higher scores indicate better quality of life or more symptoms)
Time frame
24 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Comprehensive Cancer Centre The Netherlands
Lead sponsor
Tilburg University
Collaborator
Netherlands Organisation for Scientific Research
Collaborator
Source ClinicalTrials.gov